Clarifications and explanations have been incorporated into the Guidance document Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import).
The importer of a parallel imported medicinal product must satisfy the same safety and quality requirements for the entire duration of authorisation as the marketing authorisation holder of the original medicinal product. This means that measures ordered by the market surveillance agency for the original medicinal product due to safety signals or quality defects (such as a batch-specific nitrosamine analysis) must also be implemented for placing on the market of the parallel imported medicinal product.
In addition, the new section 6.4 notes that the transfer of marketing authorisation of a parallel imported medicinal product is based on the Guidance document Transfer of marketing authorisation.
The revised Guidance document Import of a medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import) is valid from 1 January 2025.